BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOALTE NURSE CALL

    MDR report key: 16682532 · Received April 5, 2023

    Report

    Report Number
    2027454-2023-00031
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 17, 2023
    Report Date
    April 5, 2023
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761995079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VOALTE NURSE CALL SYSTEM PROVIDES VISUAL AND/OR AUDIBLE EVENT ALERT NOTIFICATION VIA DESIGNATED COMMUNICATION DEVICES. THE ROUTING OF AN ALERT TO SAID COMMUNICATION DEVICES PRIMARY AND SECONDARY IS CONFIGURED BASED ON CUSTOMER PREFERENCES. ALL CALLS ROUTE TO A PRIMARY MONITORING DEVICE GRS-10 NURSE CONSOLE, CALLS CAN ALSO TO BE CONFIGURED TO ROUTE TO SECONDARY COMMUNICATION DEVICE LOCATIONS PBX OPERATOR, WIRELESS PHONES, ETC. TROUBLESHOOTING ACTIVITIES PERFORMED BY HILLROM TECHNICIAN SUPPORT DETERMINED THE PBX CCD CONFIGURATION NEEDED TO BE CORRECTED TO RESOLVE THE ISSUE. THE CONFIGURATION WAS PROGRAMMED SO THAT THE ASSOCIATED PBX COULD MONITOR THE ASSOCIATED UNIT'S CODE BLUE CALLS. THE CUSTOMER CONFIRMED THE CONFIGURATION CHANGE WORKED AS INTENDED. NO FURTHER ASSISTANCE WAS REQUIRED BY THE CUSTOMER. IN THIS EVENT, THERE WAS NO INJURY OR IMPACT TO ANY PATIENTS, AS CONFIRMED BY THE CUSTOMER WHICH CONCLUDES A SERIOUS INJURY DID NOT OCCUR. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THE CALL ROUTED APPROPRIATELY TO THE PRIMARY LOCATION OF THE DEVICE. THE ROOT CAUSE OF THE DISASSOCIATION BETWEEN THE FACILITY'S PBX LOCATION AND THE ASSOCIATED UNIT COULD NOT BE DETERMINED. ALTHOUGH THERE WAS NO INJURY, IF A CODE BLUE CALL NOT ROUTING TO THE PBX WERE TO RESULT IN A MISSED CODE CALL NOTIFICATION IT WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. HILLROM IS CAUTIOUSLY REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CODE BLUE CALL DID NOT ROUTE, VIA VOALTE NURSE CALL SYSTEM, TO THE PBX OPERATOR LOCATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT IMPACT OR INJURY ASSOCIATED WITH THIS EVENT, THE ALERT ROUTED PROPERLY TO THE ASSOCIATED UNIT AND THAT THIS EVENT WAS NOT AN ACTUAL CODE BLUE EVENT AND THAT THE EVENT OCCURRED DURING TESTING. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348568 VOALTE NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 4.0 00887761995079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown